Ongoing Assessments

2020 Value Assessment Framework


Acute Migraine

Midwest CEPAC


CTAF, New England CEPAC

Cardiovascular Disease

Midwest CEPAC

Cystic Fibrosis


Sickle Cell Disease

New England CEPAC

Type 2 Diabetes

New England CEPAC

Ulcerative Colitis


Unsupported Price Increase Assessment


past Topics

Abuse-Deterrent Opioids

Jul 2017
New England CEPAC

Opioids are used to treat cases of acute and chronic pain that arise from a variety of causes, ranging from trauma to palliative care for advanced illness. Every year, 100 million people in the United States suffer from pain, 9-12 million of whom have chronic or persistent pain. Although opioid therapy is an important component of pain management for many patients, the addictive and euphoric properties of these drugs make them liable to misuse, abuse, addiction, and diversion.

In an effort to help tackle the public health crisis of opioid dependence, misuse, and addiction that has emerged over the last decade, drug manufacturers have begun to develop abuse-deterrent formulations of opioid medications (ADFs). ICER will review available evidence on the comparative clinical effectiveness and comparative value of ADFs in order to inform decision-making by patients, clinicians and policy-makers, within the context of multiple efforts being undertaken to combat the opioid crisis. ICER’s review will also analyze the potential of ADFs to reduce the burden of prescription opioid abuse by evaluating their benefits and market penetration based on coverage policies and legislation.

Interventions of Interest:

  • Hysingla® ER (Hydrocodone, Purdue)
  • Vantrela® (Hydrocodone , Teva)
  • Arymo® ER ( Morphine, Egalet)
  • Embeda® (Morphine + naltrexone, Pfizer)
  • MorphabondTM (Morphine extended release, Inspirion Delivery Technologies)
  • OxyContin® TR (Oxycodone, Purdue)
  • Xtampza®ER (Oxycodone, Collegium Pharmaceutical Inc)
  • Targiniq® (Oxycodone + naloxone extended release, Purdue)
  • Troxyca® ER (Oxycodone + naltrexone, Pfizer)
  • RoxyBond® (Oxycodone, Inspirion Delivery Technologies)

Date of Review: July 2017

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Alzheimer’s Disease

Jan 2013

ICER produced a comprehensive white paper on diagnostic testing for Alzheimer’s disease that was presented to the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC).

Intervention of interest: Diagnostics for Alzheimer’s disease

Date of review: January 2013

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Oct 2018
Midwest CEPAC

ICER reviewed new therapies for the treatment of hereditary transthyretin-related (hATTR) amyloidosis, a rare genetic condition characterized by nerve, heart, and eye damage that is currently treated through supportive measures alone. Therapies included inotersen (Akcea Therapeutics ), an antisense oligonucleotide that interferes with transthyretin production in the liver, and patisiran (OnpattroTM, Alnylam Pharmaceuticals), which inhibits transthyretin through an RNA interference pathway.

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Nov 2018

An estimated 22 million Americans have asthma, which causes the airways of the lungs to narrow or become blocked, making it hard to breathe. Among both young and old, asthma can have a significant impact on health and limit the ability to pursue many activities.

Interventions of Interest, 2018 review: Dupilumab (Dupixent®, Sanofi/Regeneron), omalizumab (Xolair®, Genentech/Novartis), mepolizumab (Nucala®, GlaxoSmithKline), reslizumab (Cinqair®, Teva), and benralizumab (Fasenra, AstraZeneca)

Intervention of interest, 2016 review: Mepolizumab (Nucala®, GlaxoSmithKline plc.

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Atherosclerotic Cardiovascular Disease

Nov 2018

In June 2018, ICER announced its intention to assess the comparative clinical effectiveness and value of canakinumab (Novartis) for cardiovascular risk reduction in people with atherosclerosis. However, in October 2018, when the Food and Drug Administration declined to approve canakinumab’s expanded indication for atherosclerotic cardiovascular disease, ICER announced it would no longer proceed with its value assessment.

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Atopic Dermatitis

May 2017
Midwest CEPAC

Atopic dermatitis (eczema) is a chronic/chronically-relapsing skin condition characterized by itching and dry skin. Atopic dermatitis is common. It affects 5-20% of children worldwide, and approximately 11% of children in the US. It is also estimated to affect around 3-7% of adults in the US. Management of atopic dermatitis can create burdens for the family, and the disorder can decrease quality of life. Itching, in particular, can disrupt sleep and lead to daytime sleepiness, irritability, and psychological stress, and cosmetically important lesions can lead to social stress and isolation.

ICER’s report will evaluate the comparative clinical effectiveness and value of two emerging therapies for atopic dermatitis: crisaborole and dupilumab. Crisaborole will be evaluated based on its expected indication in the treatment of mild-to-moderate atopic dermatitis in children and adults; separately, dupilumab will be evaluated for its expected indication in the treatment of moderate-to-severe atopic dermatitis in adults.

Interventions of Interest:

  • Crisaborole (Eucrisa™, Pfizer, Inc.)
  • Dupilumab (Dupixent®, Sanofi and Regeneron, Inc.)

Date of Review: May 2017

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Atrial Fibrillation

Jun 2011
ICER, New England CEPAC

Atrial fibrillation (AF) is the most common cardiac arrhythmia in the US population. AF occurs when rapid, disorganized electrical signals cause the atria (the two upper chambers of the heart) to “fibrillate”, or contract quickly and irregularly. This in turn causes some blood to pool in the atria rather than be pumped completely into the ventricles. AF can be asymptomatic but it may also be associated with several bothersome symptoms, including shortness of breath, difficulty with exercise, palpitations, general fatigue, dizziness, and confusion.

Interventions of interest:

Antiarrhythmic drugs (amiodarone, dronedarone)
Catheter ablation
Surgical ablation

Date of review: June 2011

Interventions of interest:

Antiarrhythmic drug therapy to return the heart to sinus rhythm
Radiofrequency catheter ablation to terminate AF and prevent further episodes
Minimally-invasive surgical techniques to terminate AF and prevent further episodes
Aspirin, warfarin, and dabigatran for anticoagulation to prevent strokes
The WATCHMAN left atrial appendage occlusive device to prevent strokes

Date of review: September 2010

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Attention Deficit Hyperactivity Disorder

Jun 2012
New England CEPAC

Diagnoses of Attention Deficit Hyperactivity Disorder (ADHD) have risen in recent years, and ADHD is now regarded to be a common condition among children in the United States. While reported prevalence ranges widely between 6-16% depending on location and measurement technique, it has been estimated that ADHD affects at least 5 million children aged 4-17 years in the U.S. Given the substantial burden of ADHD for children and their families, as well as the significant longterm implications that a diagnosis of ADHD carries, there is significant interest on the part of patients, clinicians, policymakers, and other stakeholders in exploring different management options for ADHD.

Interventions of interest:

Parent behavior training
School-based interventions

Date of review: June 2012

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Behavioral Health Integration

May 2015
CTAF, New England CEPAC

Providers in the US health care system often assess and treat patients with physical health conditions and behavioral health conditions (e.g., mental health and substance use disorders) in siloes, yet physical and behavioral health are inextricably linked. Up to 70% of physician visits are for issues with a behavioral health component.2 A similar proportion of adults with behavioral health conditions have one or more physical health issues.3 Having a chronic condition is a risk factor for having a behavioral health condition and vice versa.4 Depression and anxiety in particular are common in primary care settings but are often inadequately identified and treated, leading to a worsening of behavioral conditions and/or increased difficulty managing physical health conditions. Behavioral health integration (BHI) into primary care addresses both physical and behavioral health needs in primary care settings through systematic coordination and collaboration among health care providers.

Intervention of interest: Programs to integrate behavioral health into the primary care setting

Date of review: April/May 2015

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Breast Cancer Screening

Dec 2014
CTAF, New England CEPAC, Washington State

Following a negative mammogram, many women with dense breast tissue face a decision: whether to receive additional screening, and if so, what modality to use. Many mammography facilities are now informing women with dense breasts about the potential for “masking” and the increased risk of breast cancer associated with dense breast tissue. Masking occurs when breast cancers are hidden in a mammogram by dense breast tissue, which, like cancer, appears white.

Interventions of interest:

Hand-held and automated breast ultrasound
Digital breast tomosynthesis (DBT)
Magnetic resonance imaging (MRI)

Date of review: September 2013, December 2013, and December 2014

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